Standards Development

Scope

This PAS specifies requirements for DNA barcode architecture, sequence constraints and verification of engineered biological assets. The PAS is agnostic to the specific encoding methodology or external data architecture used, and assumes that barcode payloads can be linked to associated records or metadata systems appropriate to the intended application.

NOTE 1 This PAS is exclusive to engineered organisms and products emerging from synthetic biology or engineering biology practices, including those derived from genomic technologies such as gene and base editing.

NOTE 2 This PAS defines a core DNA barcode architecture and associated information requirements. Requirements relating to integration, locus confirmation and stability apply only where relevant to the intended biological asset and deployment context. Implementation-specific methods are provided as guidance unless stated otherwise.

This PAS covers:

a)    the physical DNA barcode architecture;

NOTE 3 This PAS specifies physical cassette architecture and associated information requirements. Data content encoding and mapping to external records are left to barcode scheme owners.

b)    DNA barcode sequence constraints; and

c)     verification evidence appropriate to the intended use.

This PAS does not cover natural organisms or their genetic barcoding within traditional taxonomic frameworks that use, for example, 16S rRNA (bacteria), ITS/LSU sequences (fungi), rbcL/matK (plants) or cytochrome c oxidase I (animals) sequencing.

This PAS is intended for use by the biotechnology, synthetic biology and engineering biology sectors, including:

1)    microbial biotechnology, healthcare, fermentation, food, agricultural and precision breeding biotechnology companies;

2)    research institutions and regulatory bodies;

3)    supply chain stakeholders involved in the engineering, storage, distribution and life cycle management of engineered biological assets; and

4)    academic researchers and institutions involved in developing and transferring engineered biological assets.

NOTE 4 This PAS might also be of interest to biosecurity and biosafety bodies concerned with the identity, provenance and chain of custody of engineered biological assets, including assets produced using gene editing or other genomic technologies. This PAS does not define regulatory status and is not intended to replace statutory requirements relating to the authorization, labelling, traceability, monitoring or risk assessment of genetically modified organisms, precision-bred organisms or other regulated products under applicable legislation.

NOTE 5 Lineage and versioning of assets that are subsequently re-engineered are outside the scope of this PAS; scheme owners should address these matters separately where required.